Status:
RECRUITING
Immunonutrition for Improving the Efficacy of Immunotherapy in Patients With Metastatic Non-small Cell Lung Cancer
Lead Sponsor:
Fondazione IRCCS Policlinico San Matteo di Pavia
Collaborating Sponsors:
San Luigi Gonzaga Hospital
Azienda Ospedaliera Universitaria Integrata Verona
Conditions:
Lung Cancer, Nonsmall Cell
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The present study was designed to evaluate the efficacy of the early systematic provision of oral nutritional supplements enriched in immunonutrients in non-small lung cancer patients undergoing immun...
Eligibility Criteria
Inclusion
- Confirmed histological diagnosis of metastatic non-small cell lung cancer (both squamous and non-squamous histology);
- First-line treatment with immunotherapy (alone or in combination with chemotherapy) for metastatic disease by investigators' choice within the framework of good clinical practice and in agreement with current guidelines;
- Will to participate by providing written informed consent;
- Availability to administer oral supplements and immunotherapy with or without chemotherapy;
- Eastern Cooperative Oncology Group Performance Status ≤ 2;
- Life expectancy ≥ 6 months.
Exclusion
- Age \< 18 years;
- Inability to sign an informed consent;
- Indication to or ongoing artificial nutrition support (totally compromised spontaneous food-intake) and incapacity or unavailability to consume oral nutritional supplements
Key Trial Info
Start Date :
June 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2027
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT05384873
Start Date
June 1 2023
End Date
July 31 2027
Last Update
May 1 2025
Active Locations (1)
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1
Fondazione IRCCS Policlinico San Matteo
Pavia, Italy